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Composition of fosfomycin or fosfomycin arginine salt and arginine

A technology of arginine salt and composition, applied in the field of pharmaceutical preparation, to achieve the effects of wide application range, good fluidity and stability, and easy mixing and uniformity

Inactive Publication Date: 2012-07-18
王乐
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But there is no fosfomycin arginine salt product on the market

Method used

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  • Composition of fosfomycin or fosfomycin arginine salt and arginine
  • Composition of fosfomycin or fosfomycin arginine salt and arginine
  • Composition of fosfomycin or fosfomycin arginine salt and arginine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 Preparation of the fosfomycin arginine composition of ratio 1:

[0038] In a sterile environment, 1 kg of sterile fosfomycin and 2.5 kg of sterile arginine (both calculated as dry and pure) were passed through a 60-mesh sieve and mixed in a three-dimensional mixer at a speed of 100 revolutions per minute. Mix for 1.5 hours. After mixing evenly, discharge the material, put it into an aluminum bucket for antibiotic packaging, seal it with an aluminum cover, cover it with a polyethylene plastic bag, seal it, and pack it into a box.

[0039] After packing, it is transported to the aseptic preparation subpackaging workshop, the outer packaging is removed, and the aluminum barrel is sterilized by ultraviolet light, then enters the aseptic powder subpackaging line, and is aseptically subpackaged into antibiotic glass bottles according to the specifications to obtain the preparation of the composition of the present invention. finished product.

Embodiment 2

[0040] The preparation of the fosfomycin arginine composition of embodiment 2 ratio 2:

[0041] In a sterile environment, 2.0kg of sterile fosfomycin and 3.0kg of sterile arginine (both calculated as dry and pure) were passed through a 60-mesh sieve and mixed in a three-dimensional mixer at a speed of 100 rpm. , Mix for 1.5 hours. After mixing evenly, discharge the material, put it into an aluminum bucket for antibiotic packaging, seal it with an aluminum cover, cover it with a polyethylene plastic bag, seal it, and pack it into a box.

[0042] After packing, it is transported to the aseptic preparation subpackaging workshop, the outer packaging is removed, and the aluminum barrel is sterilized by ultraviolet light, then enters the aseptic powder subpackaging line, and is aseptically subpackaged into antibiotic glass bottles according to the specifications to obtain the preparation of the composition of the present invention. finished product.

Embodiment 3

[0043] The preparation of the fosfomycin arginine composition of embodiment 3 ratio 3:

[0044] In a sterile environment, 2.0kg of sterile fosfomycin and 4.0kg of sterile arginine (both calculated as dry and pure) were passed through a 60-mesh sieve and mixed in a three-dimensional mixer at a speed of 100 rpm. , Mix for 1.5 hours. After mixing evenly, discharge the material, put it into an aluminum bucket for antibiotic packaging, seal it with an aluminum cover, cover it with a polyethylene plastic bag, seal it, and pack it into a box.

[0045] After packing, it is transported to the aseptic preparation subpackaging workshop, the outer packaging is removed, and the aluminum barrel is sterilized by ultraviolet light, then enters the aseptic powder subpackaging line, and is aseptically subpackaged into antibiotic glass bottles according to the specifications to obtain the preparation of the composition of the present invention. finished product.

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Abstract

The invention relates to a composition of two antibiotics, in particular to a composition of fosfomycin and arginine and another composition of fosfomycin arginine salt and arginine. The composition of fosfomycin and arginine consists of the fosfomycin and the arginine, wherein the optimal weight ratio of the fosfomycin to the arginine is 1:2.5. The composition of fosfomycin arginine salt and arginine consists of the fosfomycin arginine salt and the arginine, wherein the optimal weight ratio of the fosfomycin arginine salt to the arginine is 1.6:1. Both compositions can be prepared into powder injection for injection; neither compositions contains sodium ions, so that hypernatremia is not caused; and after being dissolved in 5 percent glucose or 0.9 percent sodium chloride solution, the composition can be compatible with a quinolone antibiotic for use. Thus, the composition has a wider and safer application range and is more stable and convenient to use.

Description

technical field [0001] The invention relates to fosfomycin or two compositions composed of fosfomycin arginine salt and arginine, and belongs to the technical field of medicine preparation. Background technique [0002] Fosfomycin, product alias: 1,2-epoxypropylphosphonic acid; English name: Fosfomycin, English alias: Phosphonomycin, (3-Methyloxiran-2-yl)phosphonic acid. [0003] Molecular formula: C3H7O4P, molecular weight: 138.06, CAS accession number: 23155-02-4. [0004] Fosfomycin was originally isolated from Streptomyces fradicle, and now it is synthesized. Its antibacterial mechanism is unique. By inhibiting the activity of enol pyruvate transferase, it can inhibit the early synthesis of bacterial cell walls, thereby exerting antibacterial effects. Fosfomycin has three characteristics: 1. It has a broad antibacterial spectrum, and there is no cross-resistance with other antibiotics, and most of them show synergistic effects. 2. It is safe to use, well distributed in...

Claims

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Application Information

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IPC IPC(8): A61K31/665A61K47/18A61P31/00
Inventor 王乐
Owner 王乐
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